PMCF Equity Gap Assessment.
A structured, submission-ready Post-Market Clinical Follow-Up equity gap assessment against MHRA UK PMS 2025 and EU MDR Annex XIV.
A red / amber / green scored PMCF gap map, plus written justification file and remediation plan.
Medical-device and SaMD manufacturers with a live PMS obligation post 16 June 2025.
Why this exists
UK Post-Market Surveillance obligations under Statutory Instrument 2024/1368 came into force on 16 June 2025. Passive adverse-event reporting is no longer sufficient. Manufacturers must actively look for the subgroup issue their pivotal file did not catch, or the regulator will find it first.
The 2024 UK Equity in Medical Devices Independent Review, chaired by Dame Margaret Whitehead, confirmed pulse oximeters may be less accurate in patients with darker skin. That finding has now been replicated in a 2026 pulse oximeter study. Notified bodies, HTA reviewers and NHS procurement now read every device file through this lens.
The PMCF Equity Gap Assessment maps your current PMCF plan against UK PMS 2025 and EU MDR Annex XIV requirements, and tells you, plainly, where your gap sits and what to do about it.
What is included
- Red / amber / green scored gap map across the six PMCF equity domains
- Written justification file, referenceable inside your PMS technical documentation
- Remediation plan with priorities, timelines and effort estimates
- One notified-body review-simulation session with the Unwritten Health analyst
- Editable working file, so your reg-affairs team can update as your PMCF evolves
What is not included
- Delivery of the remediation itself (that scopes to SaMD Red-Team or ESF/DTAC Pack, depending on your product)
- Ongoing PMS operations, we assess, you operate
How it works
Week 1. Kickoff and document intake. You share your current PMCF plan, PMS SOPs and any equity or subgroup analyses already in place.
Weeks 2 to 4. Structured assessment against six domains. Interviews with your PMS lead. Cross-reference against MHRA guidance and EU MDR Annex XIV.
Weeks 5 to 6. Findings, remediation plan, notified-body simulation, handover.
Where this fits
Priced at the annual line-item level of a mid-size regulatory-affairs consulting engagement. Fixed. Not scoped by burn rate. If you carry a PMS obligation, this is the cheapest defensible way to know whether you are exposed.
Take the Regulatory Readiness Scorecard.
Twenty questions, six domains. A plain-English diagnosis of your regulatory exposure, and the specific fixed-price engagement that closes each gap.